Roche cobas infinity POC Add-on User guide

Category
Network management software
Type
User guide
cobas
®
infinity POC IT solutions
POCT Management
User Guide
Publication version 1.1
Software version 1.0.1
2
Roche Diagnostics
cobas
®
infinity POC IT solutions · POCT Management · Software version 1.0.1 · User Guide · Publication version 1.1
Publication information
Publication version Software version Revision date Change description
1.0 1.0 July 2018 First version
1.1 1.0.1 September 2018 Update of supported iOS versions
y Revision history
Edition notice
This publication is intended for users of the cobas
®
infinity POC IT solutions application.
Every effort has been made to ensure that all the
information contained in this publication is correct at the
time of publishing. However, the manufacturer of this
product may need to update the publication information
as output of product surveillance activities, leading to a
new version of this publication.
General attention
To avoid incorrect results, ensure that you are familiar
with the instructions and safety information.
r Pay particular attention to all safety notices.
r Always follow the instructions in this publication.
r Do not use the software in a way that is not described
in this publication.
r Store all publications in a safe and easily retrievable
place.
Training
Do not carry out operation tasks or maintenance actions
unless you have received training from Roche
Diagnostics. Leave tasks that are not described in the
user documentation to trained Roche Service
representatives.
Images
The screenshots in this publication have been added
exclusively for illustration purposes. Configurable and
variable data in screenshots, such as tests, results, or
path names visible therein must not be used for
laboratory purposes.
Warranty
Any customer modification to the system renders the
warranty or service agreement null and void.
For conditions of warranty, contact your local sales
representative or refer to your warranty contract partner.
3
Roche Diagnostics
cobas
®
infinity POC IT solutions · POCT Management · Software version 1.0.1 · User Guide · Publication version 1.1
Copyright
© 2018, F. Hoffmann-La Roche Ltd. All rights reserved.
License information
The cobas
®
infinity POC IT solutions application is
protected by contract law, copyright law, and
international treaties. The cobas
®
infinity POC IT
solutions application contains a user license between F.
Hoffmann-La Roche Ltd. and a license holder, and only
authorized users may access the application and use it.
Unauthorized use and distribution may result in civil and
criminal penalties.
Open Source and Commercial Software
The cobas
®
infinity POC IT solutions application may
include components or modules that are commercial or
open-source software. For copyright and other notices
and licensing information regarding such software
programs, see the electronic distribution included with
this product.
The cobas
®
infinity POC IT solutions application as a
whole may form a device regulated in accordance with
applicable laws. For more detailed information, refer to
the user documentation and labelling.
Please note that the respective authorization in
accordance with applicable laws lapses in case of any
unauthorized changes to the cobas
®
infinity POC IT
solutions application.
Trademarks
The following trademarks are acknowledged:
ROCHE, ROCHE OMNI, ACCU-CHEK, COBAS B,
COBAS, and LIFE NEEDS ANSWERS are trademarks
of Roche.
Roche and the Roche symbol are registered
trademarks of the Roche group.
All other trademarks are the property of their respective
owners.
Feedback
Every effort has been made to ensure that this
publication fulfils the intended use. All feedback on any
aspect of this publication is welcome and is considered
during updates. Contact your Roche representative,
should you have any such feedback.
Languages
The application is displayed in the language defined for
each user ID in the cobas IT 1000 application system.
4
Roche Diagnostics
cobas
®
infinity POC IT solutions · POCT Management · Software version 1.0.1 · User Guide · Publication version 1.1
Disclaimer
This publication may contain information and references
to products that may not be available in your country or
sold by Roche Diagnostics. This publication makes no
claims regarding the use or performance of those
products. Selected third-party products are available for
use with the cobas
®
infinity POC IT solutions
application.
The complete list of Roche Diagnostics and third-party
products available for use with the cobas
®
infinity POC
IT solutions application in the US can be found at http://
usdiagnostics.roche.com/cobasITdevices.
Other Roche Diagnostics or third-party products listed
within the software or manuals which are not listed at
http://usdiagnostics.roche.com/cobasITdevices are not
available for use with the cobas
®
infinity POC IT
solutions application in the US.
Contact addresses
Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim
Germany
Made in Switzerland
Distributed in USA by:
Roche Diagnostics
9115 Hague Road
Indianapolis, Indiana
USA
5Table of contents
Roche Diagnostics
cobas
®
infinity POC IT solutions · POCT Management · Software version 1.0.1 · User Guide · Publication version 1.1
Table of contents
Publication information 2
Contact addresses 4
Intended use 7
Symbols and abbreviations 7
Safety
1 Safety information
Safety classifications 15
System safety 16
Safety information for IT managers 17
Operation
2 Overview of the application
About the application 23
About the intended users 24
List of user profiles 25
Overview of the user interface 26
Specifications 28
3 Using the application
Frequently performed tasks 33
Managing devices 37
Managing operators 52
Managing certifications 59
Managing QC results 64
Managing reports 76
Configuration
4 Application settings
Configuring personal settings 87
Configuring devices 88
Glossary
Index
6
Roche Diagnostics
cobas
®
infinity POC IT solutions · POCT Management · Software version 1.0.1 · User Guide · Publication version 1.1
7
Roche Diagnostics
cobas
®
infinity POC IT solutions · POCT Management · Software version 1.0.1 · User Guide · Publication version 1.1
Intended use
cobas
®
infinity POC IT solutions is an application for
managing professional Point of Care testing. It is an
application that is intended to be connected with the
cobas IT 1000 application system, which collects POC
results and associated data. The cobas IT 1000
application system automatically receives data from POC
devices and delivers this data to a server application that
can be accessed via the cobas
®
infinity POC IT
solutions application via the hospital's network for review
by professional personnel.
This product is not intended for the diagnosis, screening,
monitoring, or treatment of patients.
Symbols and abbreviations
Product names
Except where the context clearly indicated otherwise, the
following product names and descriptors are used.
Product name Descriptor
cobas
®
infinity POC IT
solutions
application
cobas IT 1000 application
system
y Product names
Symbols used in the publication
Symbol Explanation
o
List item.
u
Related topics containing further information.
q
Tip. Extra information on correct use or useful
hints.
r
Start of a task.
I
Extra information within a task.
f
Result of an action within a task.
c
Frequency of a task.
n
Duration of a task.
y Symbols used in the publication
8
Roche Diagnostics
cobas
®
infinity POC IT solutions · POCT Management · Software version 1.0.1 · User Guide · Publication version 1.1
Symbol Explanation
d
Materials that are required for a task.
j
Prerequisites of a task.
u
Topic. Used in cross-references to topics.
p
Task. Used in cross-references to tasks.
w
Figure. Used in figure titles and cross-
references to figures.
y
Table. Used in table titles and cross-references
to tables.
z
Equation. Used in cross-references to
equations.
k
Code example. Used in code titles and cross-
references to codes.
y Symbols used in the publication
Symbols used on the product
Symbol Explanation
Catalogue number
Global Trade Item Number
Date of manufacture
Manufacturer
Consult instructions for use
y Symbols used on the product
Abbreviations
The following abbreviations are used.
9
Roche Diagnostics
cobas
®
infinity POC IT solutions · POCT Management · Software version 1.0.1 · User Guide · Publication version 1.1
Abbreviation Definition
ANSI American National Standards
Institute
POC Point of Care
POCC Point of Care coordinator
POCT Point of Care testing
VPN Virtual Private Network
y Abbreviations
10
Roche Diagnostics
cobas
®
infinity POC IT solutions · POCT Management · Software version 1.0.1 · User Guide · Publication version 1.1
Roche Diagnostics
cobas
®
infinity POC IT solutions · POCT Management · Software version 1.0.1 · User Guide · Publication version 1.1
Safety
1 Safety information......................................................................................... 13
13
Table of contents
Roche Diagnostics
cobas
®
infinity POC IT solutions · POCT Management · Software version 1.0.1 · User Guide · Publication version 1.1
Safety information
In this chapter
1
Safety classifications............................................................. 15
System safety........................................................................... 16
Safety information for IT managers................................. 17
1 Safety information
14
Table of contents
Roche Diagnostics
cobas
®
infinity POC IT solutions · POCT Management · Software version 1.0.1 · User Guide · Publication version 1.1
1 Safety information
15Safety information
Roche Diagnostics
cobas
®
infinity POC IT solutions · POCT Management · Software version 1.0.1 · User Guide · Publication version 1.1
Safety classifications
The safety information applies to the system and is listed
in accordance with ANSI Z535.6-2011. The Danger safety
classification to indicate a situation that results in injury
or death is not applicable to this system and is therefore
not listed.
WARNING!
Warning
r Indicates a potentially dangerous situation which, if
ignored, may lead to fatal or severe injuries.
CAUTION!
Caution
r Indicates a potentially dangerous situation which, if
ignored, may lead to injuries and/or damage to
property.
NOTICE!
NOTICE
r Indicates a message not related to personal injury.
1 Safety information
16 System safety
Roche Diagnostics
cobas
®
infinity POC IT solutions · POCT Management · Software version 1.0.1 · User Guide · Publication version 1.1
System safety
Failure to observe the safety information may result in
incorrect results, data corruption, and data losses.
CAUTION!
Incorrect or corrupt data due to unauthorized
access
Data security is breached if unauthorized users have
access to your user name and password.
r Use strong passwords.
r Always enter your password unobserved.
r Do not write down your password.
r Never write down the password in a contact form, in
an address book or in a file on the computer.
r Do not disclose your password to anyone. Roche
never asks you for your password.
r If you ever disclose your password to anyone, change
it immediately after.
r If you think anyone else has access to your account,
contact your Roche Service representative
immediately.
NOTICE!
Access to wrong device
Delayed troubleshooting or unnecessary maintenance of
a device accessed remotely.
r When you access a device remotely, check that the IP
address displayed corresponds to the one configured
for the device.
1 Safety information
17Safety information
Roche Diagnostics
cobas
®
infinity POC IT solutions · POCT Management · Software version 1.0.1 · User Guide · Publication version 1.1
Safety information for IT managers
The IT manager of your organization should ensure that
the following safety measures are implemented.
Data security
CAUTION!
Monitor the system for suspicious activity and
report suspected compromise
If you find any of the typical signs of malicious software
or unauthorized access to the system (unexpected
warning messages, files, or log entries like multiple
failed logon attempts; significantly degraded user
interface performance; seemingly random crashes of the
system; automated typing of text; and so on), the
following recommendations are essential:
r Physically disconnect the system from the network.
r Contact the IT responsible in your organization to
report and verify the finding.
r Mistrust results produced while the system has been
compromised.
r Contact your Roche Service representative to initiate
the system recovery.
1 Safety information
18 Safety information for IT managers
Roche Diagnostics
cobas
®
infinity POC IT solutions · POCT Management · Software version 1.0.1 · User Guide · Publication version 1.1
CAUTION!
Data loss or unavailability of the system due to
malicious software or unauthorized system access
Malicious software or unauthorized system access can
result in data loss or system unavailability.
To avoid infection by malicious software or the
unauthorized access and misuse of the system, the
following recommendations are essential:
r Make sure other computers and services on the
network (for example, the LIS, archiving share,
backup share, or service) are properly secured and
protected against malicious software and
unauthorized access.
r Restrict physical access to the system and all
attached IT infrastructure (computer, cables, network
equipment, and so on).
r Check all external storage devices, like CDs, DVDs, or
USB mass storage devices with an antivirus software
(on another computer) to ensure that they are free of
malicious software, before using them on the system.
r Use state-of-the-art security mechanisms (e.g. WPA2
EAP) to protect Wi-Fi connections.
r Allow only defined users to read and write encryption
keys (IIS App config / Windows Server Hardening).
r Allow only internet access to trusted web sites and
web services.
r Enable Data Execution Prevention for all applications
(Windows Server).
r Make sure to use secure channels to download
software updates of the system.
1 Safety information
Roche Diagnostics
cobas
®
infinity POC IT solutions · POCT Management · Software version 1.0.1 · User Guide · Publication version 1.1
Operation
2 Overview of the application....................................................................... 21
3 Using the application................................................................................... 31
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Roche cobas infinity POC Add-on User guide

Category
Network management software
Type
User guide

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